The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

Device Description

The DigitalDiagnost C90 is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE (K170113 - February 9, 2017), together with the tube these components form the radiography Image Chain. As additional options, a portable detector (K141736 - July 25, 2014) can be used for free exposures as well as in the patient support table or in the vertical stand.

AI/ML Overview

The provided text describes the Philips DigitalDiagnost C90, a stationary X-ray system, and states that it did not require a clinical study. Instead, substantial equivalence was demonstrated through non-clinical performance testing and validation.

However, the document does not contain a table of acceptance criteria or details of a study that proves the device meets specific acceptance criteria related to its performance beyond general safety and equivalence to a predicate device. It confirms that the device meets "the acceptance criteria" in general, but does not quantify them or describe the study in detail.

Therefore, many of the requested elements cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be provided based on the input:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided. The document states "The test results demonstrate that the proposed DigitalDiagnost C90 meets the acceptance criteria," but does not specify what those criteria are or report detailed device performance against them. It focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to consensus standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be provided. The document refers to "nonclinical verification and validation tests as well as image quality testing" but gives no details about the sample size of any test sets or the provenance of any data used in these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Cannot be provided. Since no specific clinical or performance study with a test set and ground truth is detailed, information about experts and their qualifications is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Cannot be provided. No details on adjudication methods for a test set are mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Cannot be provided. The document explicitly states: "The proposed DigitalDiagnost C90 did not require a clinical study". Therefore, no MRMC study with AI assistance was performed or described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Cannot be provided. The device is an X-ray system, not primarily an AI algorithm. Its performance is evaluated as an imaging system, and no standalone algorithm performance is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Cannot be provided. As no specific performance study is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set:

Cannot be provided. The document does not describe any machine learning or AI components that would require a "training set" in the context of X-ray image interpretation or diagnostics. The device is a radiographic image acquisition, processing, storage, display, and export system.

9. How the ground truth for the training set was established:

Cannot be provided. As no training set is discussed, how its ground truth was established is not relevant or provided.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device (Philips Eleva Workspot for DigitalDiagnost K141736) through comparisons of technological characteristics, adherence to recognized standards for safety and performance (e.g., ISO 14971, IEC 60601 series), and non-clinical testing for verification and validation. It explicitly states that a clinical study was not required. No specific "acceptance criteria" table or quantitative performance data from a dedicated study assessing diagnostic accuracy or similar metrics are present.

Summary

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Philips Medical Systems DMC GmbH Ming Xiao Regulatory Affairs Manager Roentgenstrasse 24 Hamburg, 22335 DE GERMANY

January 11, 2019

Re: K182973

Trade/Device Name: DigitalDiagnost C90 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, KPR, LLZ Dated: October 23, 2018 Received: October 26, 2018

Dear Ming Xiao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara For

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182973

Device Name

DigitalDiagnost C90

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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7. 510(k) Summary

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared: revised January 09, 2019
Manufacturer: Philips Medical Systems DMC GmbH Röntgenstraße 24 22335 Hamburg GERMANY Establishment registration number: 3003768251
Contact Person: Ming Xiao Regulatory Affairs Manager Phone: +49 40 34971-2306 Fax: +49 40 5078-2425 E-mail: ming.xiao@philips.com
Device Name: DigitalDiagnost C90

Classification:	Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
	Classification Regulation: 21CFR 892.1680
	Regulation Description: Stationary x-ray system
	Classification Panel: 90 -- Radiology
	Device Class: Class II
	Classification Product Code: MQB
	Secondary Product Codes: KPR, LLZ
Predicate Device:	Trade Name: Philips Eleva Workspot for DigitalDiagnost
	Manufacturer: Philips Medical System DMC
	510(k) Clearance: K141736 - July 25, 2014
	Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
	Classification Regulation: 21CFR 892.1680
	Classification Panel: 90 -- Radiology
	Device Class: Class II
	Product code: MQB
	Subsequent Product Code: KPR

DigitalDiagnost C90 Premarket Notification – Traditional 510(k) Page 1 of 13

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Reference	Trade Name:	Philips Bucky Vision
Device_1 (primarydevice):	Manufacturer:	Philips Medical System DMC
	510(k) Clearance:	K982795 - November 24, 1998
	Classification Name:	Solid State X-Ray Imager (FlatPanel/Digital Imager)
	Classification Regulation:	21CFR 892.1680
	Classification Panel:	90 -- Radiology
	Device Class:	Class II
	Product code:Subsequent Product Code:	MQBKPR
Reference	Trade Name:	Eleva Workspot with SkyFlow
Device_2:	Manufacturer:	Philips Medical System DMC
	510(k) Clearance:	K153318 - December 22, 2015
	Classification Name:	Solid State X-Ray Imager (FlatPanel/Digital Imager)
	Classification Regulation:	21CFR 892.1680
	Classification Panel:	90 -- Radiology
	Device Class:	Class II
	Product code:Subsequent Product Code:	MQBLLZ
Reference	Trade Name:	Pixium 4343RCE
Device_3:	Manufacturer:	Philips Medical System DMC
	510(k) Clearance:	K170113 – February 9, 2017
	Classification Name:	Solid State X-Ray Imager (FlatPanel/Digital Imager)
	Classification Regulation:	21CFR 892.1680
	Classification Panel:	90 -- Radiology
	Device Class:	Class II
	Product code:	MOB

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Device Description:

The proposed DigitalDiagnost C90 is considered substantially equivalent to the currently marketed and predicate device, Philips Eleva Workspot for DigitalDiagnost (K141736, July 25, 2014), previously designated with primary product code MQB and subsequent product code LLZ, in terms of indications for use and design characteristics. Nevertheless product code KPR -being also considered substantially equivalent- (based upon submission Philips Bucky Vision (K982795, November 24, 1998) is chosen for this new submission, because it refers back to a complete "stationary x-ray system".

The proposed DigitalDiagnost C90 incorporates the following features, previously cleared by FDA in the following reference devices:

Design Feature/ Attribute	Currently Marketed and Reference Device - Philips Medical Systems
Primary device	Philips Bucky Vision (K982795, November 24, 1998)
Image Chain acquisition-station and workflow (Eleva Workspot)	Eleva Workspot with SkyFlow (K153318, December 22, 2015)
Fixed static detector	Pixium RCE (K170113, February 9, 2017)

The Indications for Use for the proposed DigitalDiagnost C90 are as follows:

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Device History / Predicate Device for DigitalDiagnost C90:

510(k)	DecisionDate	ClearedDevice	ProductCode	PredicateDevice	Intended Use	Release Product
K982795	24.11.1998	PhilipsBuckyVision	MQB, KPR	K945278	The PhilipsBuckyVision isintended for usein general radio-graphic exam-inations andapplicationswherever con-ventionalscreen-filmsystem may beused (excludingfluoroscopy,angiographyand mammo-graphy).	DigitalDiagnostRelease 1 (issuedas Bucky Visionfor cleared510(k)declarationK982795 in1998)
K063781	05.01.2007	Philips XD-S DirectRadiographyWorkstation/Package	LLZ, MQB	K982795	As part of aradiographicsystem, thePhilips XD-Sis intended toacquire,process, store,display andexport digitalradiographicimages. ThePhilips XD-S issuitable for allroutine radio-graphy exams,includingspecialist areaslike intensivecare, trauma, orpediatric work,excludingmammography.	DigitalDiagnostRelease 2
K090625	24.03.2009	WirelessPortableDetectorFD-W17	MQB	K982795 K063781	As part of aradiographicsystem, theWirelessPortableDetector FD-W17 is intendedto acquiredigital radio-graphic images.The WirelessPortable	DigitalDiagnostRelease 3
510(k)	DecisionDate	ClearedDevice	ProductCode	PredicateDevice	Intended Use	Release Product
					Detector FD-W17 is suitablefor all routineradiographyexams,includingspecialist areaslike intensivecare, trauma, orpediatric work,excludingfluoroscopy,angiographyand mammo-graphy.
K131483	07.10.2013	PhilipsPixium4343RC	MQB	K982795 K063781 K090625	As part of aradiographicsystem, thePhilips Pixium4343RC isintended toacquire digitalradiographicimages. ThePhilips Pixium4343RC issuitable for allroutine radio-graphy exams,includingspecialist areaslike intensivecare, trauma, orpediatric work,excludingfluoroscopy,angiographyandmammography.	DigitalDiagnostRelease 4
K141736	25.07.2014	PhilipsElevaWorkspotforDigitalDiagnost	MQB, LLZ	K090625	As part of aradiographicsystem, thePhilips ElevaWorkspot withSkyPlateDetectors isintended toacquire,process, store,display andexport digitalradiographic	DigitalDiagnostRelease 4 withSkyPlateDetectors
510(k)	Decision Date	Cleared Device	Product Code	Predicate Device	Intended Use	Release Product
K18xxxx		DigitalDiagnost C90	MQB, LLZ, KPR	K141736	images. The Philips Eleva Workspot with SkyPlate Detectors is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.The Digital-Diagnost C90 is intended to acquire, process, store, display and export digital radio-graphic images. The Digital-Diagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography	DigitalDiagnost C90

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Fundamental Scientific Technology:

The DigitalDiagnost C90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost (K141736, July 25, 2014), with regards to the functionality of the following components: table, system-control, X-Ray tube, detector, and generator etc. (see the comparison table comparing

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the DigitalDiagnost C90 to the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost provided below).

The DigitalDiagnost C90 employs the following cleared features: fixed RAD detector (Pixium 4343RCE, K170113, February 9, 2017), wireless detectors (SkyPlate Detector, cleared by Eleva Workspot for DigitalDiagnost, K141736, July 25, 2014)) and the image chain acquisition-station and workflow (Eleva Workspot with SkyFlow, K153318, December 22, 2015). The fixed detector, wireless portable detectors, and the image chain and workstation of the DigitalDiagnost C90 are identical to the fixed detector, wireless portable detectors, and the image chain and workstation of the currently marketed and reference devices. Therefore, the fixed detector, wireless portable detectors, and the image chain and workstation employ identical fundamental scientific technology.

The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the DigitalDiagnost C90 when compared to the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost.

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Summary of technological characteristics: .

The DigitalDiagnost C90 has similar indications for use and technological characteristics as the predicate device, Philips Eleva Workspot for DigitalDiagnost. Comparisons of the technological characteristics demonstrate the substantial equivalence to the predicate device.

	Predicate Device:Philips Eleva Workspotfor DigitalDiagnostRelease 4 with SkyPlateDetectors / (K141736)	Proposed Device:DigitalDiagnost C90(K18xxxx)	Discussion & Conclusion
Table Features
Height adjustable table (TH)
Height adjustment	51.5 cm to 91.5 cmabove floor, motorizedadjustment	51.5 cm to 91.5 cmabove floor, motorizedadjustment	Equivalent; No impact tosafety or effectiveness ofthe device.
Table weight	335 kg	335 kg	Equivalent; No impact tosafety or effectiveness ofthe device.
Max. patientweight	Static load center: 375kgDynamic load center:318 kgDynamic load off center:210 kg	Static load center: 375kgDynamic load center:318 kgDynamic load offcenter: 210 kg	Equivalent; No impact tosafety or effectiveness ofthe device.
Table top Type	Floating table top ofsandwich design withGetalit overlay	Floating table top ofsandwich design withGetalit overlay	Equivalent; No impact tosafety or effectiveness ofthe device.
Table topDimension	240 cm x 75 cm	240 cm x 75 cm	Equivalent; No impact tosafety or effectiveness ofthe device.
Table top travel	• longitudinal: ±60 cm• transverse: ±13 cm,electromagneticbrakes	• longitudinal: ±60cm• transverse: ±12 cm,electromagneticbrakes	Similar: Minor differencesin the table top travel doesnot affect the safety oreffectiveness of the device.
Single side suspended table (TH-S)
Height adjustment	50.3 cm to 90.3 cmmotorized adjustment	50.3 cm to 90.3 cmmotorized adjustment	Equivalent; No impact tosafety or effectiveness ofthe device.
Table weight	214 kg	214 kg	Equivalent; No impact tosafety or effectiveness ofthe device.
Max. patientweight	225 kg	•table top center: 225kg•end of table top: 135kg	Equivalent; No impact tosafety or effectiveness ofthe device.
Table top Type	Floating table top ofsandwich design withKevlar overlay, flat top	Floating table top ofsandwich design withKevlar overlay, flattop	Equivalent; No impact tosafety or effectiveness ofthe device.
	Predicate Device:Philips Eleva Workspotfor DigitalDiagnostRelease 4 with SkyPlateDetectors / (K141736)	Proposed Device:DigitalDiagnost C90(K18xxxx)	Discussion & Conclusion
Table topDimension	260 cm x 75 cm	260 cm x 75 cm	Equivalent; No impact tosafety or effectiveness ofthe device.
Thickness of tabletop	4.7 cm	4.7 cm	Equivalent; No impact tosafety or effectiveness ofthe device.
Table top travel	• longitudinal: ±20 cm,hydraulic brakes• transverse: ±20 cm,hydraulic brakes	• longitudinal: ±20cm, hydraulicbrakes• transverse: ±20 cm,hydraulic brakes	Equivalent; No impact tosafety or effectiveness ofthe device.
Patient coveragewith fixed RADdetector	• longitudinal: 208 cm• Transversal: 83 cm	• longitudinal: 208cm• Transversal: 83 cm	Equivalent; No impact tosafety or effectiveness ofthe device.
Celling Suspension CSM
Type	Four-part aluminumtelescopic column withspring counter balancedholder for X-ray tubeassembly; adaptable toindividual room heights	Four-part aluminumtelescopic column withspring counterbalanced holder for X-ray tube assembly;adaptable to individualroom heights	Equivalent; No impact tosafety or effectiveness ofthe device.
Ceiling height atsource imagedistance 110 cm	2.83 m to 3.21 m	2.65 m to 3.20 m	Similar: Minor differencesin the Ceiling height doesnot affect the safety oreffectiveness of the device.
Movement	3.28 m to 3.44 m	3.28 m to 3.44 m	Equivalent; No impact tosafety or effectiveness ofthe device.
Transverse travel	1.50 m to 3.22 m	1.49 m to 3.21 m	Similar: Minor differencesin the Transverse travel donot affect the safety oreffectiveness of the device.
Vertical travel	1.65 m	1.65 m	Equivalent; No impact tosafety or effectiveness ofthe device.
X-ray tubeassembly rotation	• around vertical axis:360° (±180°) withlock position every45°• around horizontalaxis: ±125°, lockpositions 0° and ±90°	• around vertical axis:360° (±180°) withlock position every45°• around horizontalaxis: ±125°, lockpositions 0° and±90°	Equivalent; No impact tosafety or effectiveness ofthe device.
	Predicate Device:Philips Eleva Workspotfor DigitalDiagnostRelease 4 with SkyPlateDetectors / (K141736)	Proposed Device:DigitalDiagnost C90(K18xxxx)	Discussion & Conclusion
Length of rails	4.3 m	4.3 m	Equivalent; No impact tosafety or effectiveness ofthe device.
Collimator	• Ralco P 225 ACSDHHS• Motorized automaticcollimation• Manual overrulepossible• With light fieldindicator	• Ralco P 225 ACSDHHS• Motorized auto-matic collimation• Manual overrulepossible• With light fieldindicator• With 2 Lasers andCamera	Ralco Collimator R225ACS is cleared by RalcoK091517 (on 14, July2009), Ralco P 225 ACSDHHS is cleared by Letterto File on 02, February2016 based on K091517.Laser and Camera arealready certified and clearedas options in K091517.Equivalent; No impact tosafety or effectiveness ofthe device.
	Vertical StandVertical moveable stand (VM)
Hardware	Counterbalanced ruggedcolumn for motorizedvertical movement of thedetector unit	Counterbalancedrugged column formotorized verticalmovement of thedetector unit	Equivalent; No impact tosafety or effectiveness ofthe device.
Vertical travel	35 cm to 185 cm	35 cm to 185 cm	Equivalent; No impact tosafety or effectiveness ofthe device.
Horizontal travel	• Motorized: 3.475 m• non-motorized: 3.71 m• with extension rails,motorized: 5.5 m• with extension rails,non-motorized: 5.5 m	• Motorized: 3.475 m• with extension rails,motorized: 5.5 m	Equivalent; No impact tosafety or effectiveness ofthe device.
Swiveling range	0° to 90° (right or leftorientated execution)	0° to 90° (right or leftorientated execution)	Equivalent; No impact tosafety or effectiveness ofthe device.
Lock-in positions	manual or every 15°	manual or every 15°	Equivalent; No impact tosafety or effectiveness ofthe device.
	Fixed Vertical Stand (VS)
Hardware	Counterbalanced ruggedcolumn for motorizedand manual verticalmovement of the detector	Counterbalancedrugged column formotorized and manualvertical movement ofthe detector	Equivalent; No impact tosafety or effectiveness ofthe device.
Vertical travel	30 cm to 180 cm	30 cm to 180 cm	Equivalent; No impact tosafety or effectiveness ofthe device.
	Predicate Device:Philips Eleva Workspotfor DigitalDiagnostRelease 4 with SkyPlateDetectors / (K141736)	Proposed Device:DigitalDiagnost C90(K18xxxx)	Discussion & Conclusion
Installation	Floor and wall attachment or floor only	Floor and wall attachment or floor only	Equivalent; No impact to safety or effectiveness of the device.
Fixed RADDetector	Pixium 4343RC	Pixium 4343RCE	The proposedDigitalDiagnost C90includes the fixed RADdetector Pixium 4343RCEused in the currentlymarketed and referencedevice, Pixium 4343 RCE(K170113). Therefore,there is no impact on thesafety or effectiveness ofthe device.
Wireless StaticDetector	SkyPlate Detector family	SkyPlate Detectorfamily	Equivalent; No impact to safety or effectiveness of the device.
Generator	High-voltage generator 65kW or 80kW	High-voltage generator 65kW or 80kW	Equivalent; No impact to safety or effectiveness of the device.
Tube	High power X-ray Tube, Philips SRO 33100	High power X-rayTube, Philips SRO33100	Equivalent; No impact to safety or effectiveness of the device.
SkyFlow	No	Yes	The proposedDigitalDiagnost C90includes the SkyFlow usedin the currently marketedand reference device ElevaWorkspot with SkyFlow,(K153318). Therefore,there is no impact on thesafety or effectiveness ofthe device.
Eleva Workspot	Yes	Yes	Equivalent; No impact to safety or effectiveness of the device.
SkyPlate DetectorSharing	Yes	Yes	Equivalent; No impact to safety or effectiveness of the device.
Automatic Imagestitching	Yes	Yes	Equivalent; No impact to safety or effectiveness of the device.
Indications for Use	As part of a radiographicsystem, the Philips ElevaWorkspot with SkyPlateDetectors is intended toacquire, process, store,display and export	The DigitalDiagnostC90 is intended toacquire, process.store, display andexport digital radio-graphic images. The	Equivalent; The Indicationsfor Use for the proposedDigitalDiagnost C90 ismore general in nature andexactly the same as thecurrently marketed and
Predicate Device:Philips Eleva Workspotfor DigitalDiagnostRelease 4 with SkyPlateDetectors / (K141736)	Proposed Device:DigitalDiagnost C90(K18xxxx)	Discussion & Conclusion
digital radiographicimages. The PhilipsEleva Workspot withSkyPlate Detectors issuitable for all routineradiography exams,including specialist areaslike intensive care,trauma, or pediatricwork, excludingfluoroscopy, angio-graphy &mammography.	DigitalDiagnost C90 issuitable for all routineradiography exam-inations, includingspecialist areas likeintensive care, traumaor pediatric work,excluding fluoroscopy,angiography andmammography.	reference device, PhilipsEleva Workspot forDigitalDiagnost(K141736).

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DigitalDiagnost C90 Premarket Notification – Traditional 510(k)

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DigitalDiagnost C90 Premarket Notification – Traditional 510(k)

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Based on the information provided above, the DigitalDiagnost C90 is considered substantially equivalent to the currently marketed and predicate device, Philips Eleva Workspot for DigitalDiagnost (K141736, July 25, 2014) in terms of fundamental scientific technology.

Summary of Non-Clinical Data:

This 510(k) premarket notification contains technical documentation which includes nonclinical verification and validation tests as well as image quality testing. Tests were performed on the proposed DigitalDiagnost C90 according to the following international and FDArecognized consensus standards:

ISO 14971, Medical devices. Application of risk management to medical devices ●
. IEC 60601-1, Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems
IEC 60601-1-2. Medical electrical equipment. General requirements for basic safety and ● essential performance. Collateral Electromagnetic compatibility. Requirements and tests
. IEC 60601-1-3. Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
. IEC 60601-2-54, Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
. IEC 6220-1, Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
IEC 62304, Medical device software. Software life-cycle processes
IEC 60601-1-6. General requirements for basic safety and essential performance -. Collateral standard: Usability
Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issued ●

DigitalDiagnost C90 Premarket Notification - Traditional 510(k) Page 12 of 13

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September 1, 2016

. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
Pediatric Information for X-ray Imaging Device Premarket Notifications, Draft, issued May 10, 2012
Guidance for the Submission of Premarket Notifications for Medical Image ● Management Device, issued July 27, 2000

The test results demonstrate that the proposed DigitalDiagnost C90 meets the acceptance criteria and is adequate for its intended use.

Based upon the same intended use, similar technology, software functionalities, same product configuration and administration, and similarity of materials, it can be concluded the proposed DigitalDiagnost C90 is substantially equivalent to the predicate device, Philips EasyDiagnost Eleva, in terms of intended use, design characteristics, and safety and effectiveness.

The subject device DigitalDiagnost C90 is a combination of cleared Philips devices (Eleva Workspot, Bucky Vision, Pixium 4343RCE). Testing for integration of devices into a fullyfunctional system has been successfully performed.

Summary of Clinical Data:

The proposed DigitalDiagnost C90 did not require a clinical study since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes:

. Design features;
Indication for use;
Fundamental scientific technology:
Non-clinical performance testing including validation; and
. Safety and effectiveness.

Substantial Equivalence Conclusion:

The comparison of technological characteristics, non-clinical performance data, safety testing, software validation, and clinical image concurrence data demonstrates that the device is as safe and effective as the predicate device. Philips Medical Systems concludes that the proposed DigitalDiagnost C90 is substantially equivalent to the legally marketed predicate device, Philips Eleva Workspot for DigitalDiagnost.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.